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Completed

NCT Number: NCT07254676

Virtual Reality-Enhanced Rehabilitation for Upper Limb Recovery in Acute Post-Stroke Patients

Post-stroke rehabilitation is essential for maximising motor recovery. Virtual reality (VR) is emerging as a promising adjunct to conventional therapy (CRT), potentially enhancing upper limb motor outcomes. The goals of the study are:

1. To evaluate the efficiency of VR in addition to CRT on upper limb function in the acute phase of post-stroke rehabilitation, which is underrepresented in the literature. 2. To explore the relationship between cognitive impairment and upper limb motor recovery using VR.

The investigators hypothesise that combining VR and CRT improves upper limb functional outcomes in acute stroke beyond the effects of CRT.

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Key information

Conditions

Acute Stroke Intervention Rehabilitation Exercise

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Maribor, Ljubljanska 5 Maribor, Slovenia

Maribor, 2000, Slovenia

About this study

The investigators will conduct a prospective randomised single- blind pilot controlled trial to evaluate the efficacy of VR-based rehabilitation with the Bimeo PRO system in improving upper limb function in acute post-stroke patients. Participants will be randomly assigned to a two-week program of VR training combined with conventional therapy (experimental group) or conventional therapy alone (control group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults ≥18 years.
  • First-ever acute stroke, occurring <7 days before therapy start.
  • Upper-limb activity limitation with some preserved function (e.g., ability to grasp).
  • Able to understand instructions and provide informed consent.

Exclusion criteria

  • Severe cognitive impairment that precludes following instructions.
  • Aphasia or severe visual/hearing impairment that prevents meaningful participation.
  • End-stage/terminal illness.

Treatment and study plan

Virtual Reality-enhanced rehabilitation

Behavioral

Dose of practice and difficulty:

In each VR session, participants will perform three tasks, completing one trial of each-reaching, tracking, and labyrinth-with no within-session repetitions. Across ten sessions, participants will complete ten trials of each task (30 trials in total). Task difficulty will be fixed and identical for all participants throughout the intervention (no automatic progression or therapist-driven difficulty changes).

Adherence, tolerability, and adverse events:

Participants will be scheduled to complete the prescribed VR dose (10 sessions; 150 minutes total). Adherence will be recorded at each session. Serious adverse events are not expected; all adverse events will be actively monitored and documented.

Conventional rehabilitation therapy (CRT)

Other

Physiotherapy and occupational therapy: manual therapy techniques, passive and active-assisted mobilisation, scapular mobilisation, and task-specific training such as horizontally moving an object across a surface), 60 minutes per session.

Other names: physiotherapy, occupational therapy

Primary outcomes

  1. The Fugl-Meyer Upper Extremity Assessment (FMA-UE)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    Fugl-Meyer Upper Extremity Assessment (FMA-UE). Will evaluate post-stroke body functions-motor function, sensation, passive joint motion, and joint pain. Scoring will sum all item scores to a total of 0-126, with higher scores indicating better function.

  2. The Wolf Motor Function Test (WMFT)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    Wolf Motor Function Test (WMFT). Will assess upper-limb performance with 17 items (2 strength items and 15 timed tasks) that progress from proximal to distal/whole-limb movements. Outcomes will include task times and the Functional Ability Scale (FAS); the mean FAS will be computed as total FAS/15 (range 0-5).

  3. Grip strength

    Time frame: Change from baseline to 2 weeks (end of intervention)

    Grip strength. Will be measured in kilograms using a calibrated hand dynamometer. Participants will perform three maximal efforts with the affected hand while seated (elbow 90°, forearm neutral); the best of three will be recorded for analysis.

Secondary outcomes

  1. The National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The NIHSS is a comprehensive assessment tool used to evaluate the severity of a stroke. The scale generates scores ranging from 0, denoting the absence of deficits, to 46, signifying severe impairment.

  2. The Modified Rankin Scale (mRS)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The Modified Rankin Scale (mRS) is a widely utilised and reliable functional assessment tool in clinical trials for stroke patients. Deviating from task-specific evaluations, the mRS measures the level of independence on a scale of 0 to 6.

  3. The Montreal Cognitive Assessment (MoCA)

    Time frame: Change from baseline to 2 weeks (end of intervention)

    The Montreal Cognitive Assessment (MoCA) serves as a cognitive screening instrument, encompassing the evaluation of visuospatial/executive function, naming, memory, attention, language, abstraction, recall, and orientation.

Sponsors and collaborators

Lead sponsor

University Medical Centre Maribor

Other

Registry information

Official study title

Effects of Virtual Reality-Enhanced Rehabilitation on Upper Limb Recovery in Acute Post-Stroke Patients: a Pilot Study

Acronym: VR

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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